check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
15141
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
15141 Fixed dose correction / naïve and pre dialysis (Europe and Asia Pacific)
Trial purpose
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body’s ability to produce erythropoietin.
The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 5 hospitals in the UK.
Bayer HealthCare AG is funding this research.
The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 5 hospitals in the UK.
Bayer HealthCare AG is funding this research.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
121Trial Dates
February 2014 - September 2015Phase
Phase 2Could I Receive a placebo
YesProducts
Molidustat (BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pavia, 27100, Italy | |
Completed | Cremona, 26100, Italy | |
Withdrawn | Milano, 20132, Italy | |
Completed | Livorno, 57023, Italy | |
Withdrawn | Reservoir, 3073, Australia | |
Completed | Gosford, 2250, Australia | |
Completed | Melbourne, 3052, Australia | |
Withdrawn | London, United Kingdom | |
Completed | Cambridge, CB2 0QQ, United Kingdom | |
Withdrawn | Liverpool, L7 8XP, United Kingdom | |
Completed | London, SE5 9RS, United Kingdom | |
Completed | Doncaster, DN2 5LT, United Kingdom | |
Withdrawn | Nagano, 388-8004, Japan | |
Completed | Kitakyushu, 802-8555, Japan | |
Completed | Muroran, 050-0083, Japan | |
Completed | Fukuoka, 810-8563, Japan | |
Completed | Düsseldorf, 40210, Germany | |
Withdrawn | Pirmasens, 66953, Germany | |
Withdrawn | Berlin, 12053, Germany | |
Completed | Pecs, 7623, Hungary | |
Withdrawn | Debrecen, 4032, Hungary | |
Completed | Targu-Mures, 540103, Romania | |
Completed | Oradea, 410469, Romania | |
Withdrawn | Bucharest, 050098, Romania | |
Completed | Pazardjik, 4400, Bulgaria | |
Completed | Veliko Tarnovo, 5000, Bulgaria | |
Completed | Montana, 3400, Bulgaria | |
Completed | Lovech, 5500, Bulgaria | |
Withdrawn | Sofia, 1431, Bulgaria | |
Withdrawn | Sofia, 1527, Bulgaria | |
Completed | Bucheon-si, 420-767, Korea, Republic Of | |
Completed | Modena, 41100, Italy | |
Withdrawn | Chieti, 66013, Italy | |
Completed | Bucharest, 020475, Romania | |
Withdrawn | Fujisawa, 251-8550, Japan | |
Completed | Kamakura, 247-8533, Japan | |
Withdrawn | Bucharest, 010731, Romania | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Withdrawn | Alicante, 03010, Spain | |
Withdrawn | Córdoba, 14004, Spain | |
Withdrawn | Burgas, 8000, Bulgaria | |
Completed | Baja, 6500, Hungary | |
Withdrawn | PIERRE BENITE CEDEX, 69495, France | |
Withdrawn | PARIS CEDEX 15, 75908, France | |
Withdrawn | GRENOBLE CEDEX 9, 38043, France | |
Withdrawn | PERPIGNAN CEDEX 9, 66046, France | |
Withdrawn | MARSEILLE CEDEX 5, 13385, France | |
Withdrawn | REIMS cedex, 51092, France | |
Completed | Constanta, 900591, Romania | |
Completed | Kuwana, 511-0061, Japan | |
Completed | Stara Zagora, 6000, Bulgaria | |
Completed | Gabrovo, 5300, Bulgaria | |
Withdrawn | Kaposvar, 7400, Hungary | |
Withdrawn | Szigetvar, 7900, Hungary | |
Completed | Okawa, 831-0016, Japan | |
Completed | Poznan, 61-858, Poland | |
Completed | Radom, 26-610, Poland | |
Withdrawn | Valenciennes, 59300, France | |
Completed | LIMOGES Cedex1, 87042, France | |
Withdrawn | BREST CEDEX, 29609, France | |
Withdrawn | Wuppertal, 42283, Germany | |
Completed | Bialystok, 15-540, Poland | |
Completed | Chiba, 260-8712, Japan | |
Completed | Szczecin, 70-111, Poland | |
Completed | Bonn, 53127, Germany | |
Completed | Seoul, 156-707, Korea, Republic Of | |
Completed | Seoul, 156-755, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Zyrardow, 96-300, Poland | |
Completed | Malbork, 82-200, Poland | |
Completed | Halle (Saale), 06097, Germany | |
Completed | Hakusan, 924-8588, Japan | |
Completed | Nara, 630-8581, Japan | |
Completed | Morioka, 020-0066, Japan | |
Withdrawn | Milano, 20162, Italy | |
Completed | Napoli, 80138, Italy | |
Withdrawn | Kfar Saba, 4428164, Israel | |
Completed | Ashkelon, 7827804, Israel | |
Withdrawn | Dobrich, 9300, Bulgaria | |
Withdrawn | Brescia, 25123, Italy | |
Completed | Hadera, 3810101, Israel | |
Completed | Nahariya, 2210001, Israel | |
Withdrawn | Jerusalem, 9112001, Israel | |
Terminated | Ankara Univ. Medical Faculty | Ankara, 06100, Turkey |
Terminated | Baskent University Medical Faculty | Ankara, 06490, Turkey |
Terminated | Sifa University Medical Faculty | IZMIR, 03540, Turkey |
Withdrawn | Salford, M6 8HD, United Kingdom | |
Completed | Budapest, 1036, Hungary | |
Withdrawn | Sofia, 1872, Bulgaria | |
Withdrawn | Karlovo, 4300, Bulgaria | |
Completed | Villingen-Schwenningen, 78052, Germany | |
Withdrawn | San Dimas, 91773, United States | |
Withdrawn | Lynwood, 90262, United States | |
Withdrawn | Ontario, 90022, United States | |
Withdrawn | Chorley, PR7 7NA, United Kingdom | |
Withdrawn | Hexham, NE46 1QJ, United Kingdom | |
Withdrawn | Manchester, M15 6SX, United Kingdom | |
Withdrawn | Glasgow, G20 OSP, United Kingdom | |
Completed | Santiago de Compostela, 15706, Spain | |
Withdrawn | Liverpool, L22 0LG, United Kingdom | |
Withdrawn | Birmingham, B15 2SQ, United Kingdom | |
Withdrawn | Reading, RG2 0TG, United Kingdom |
Primary Outcome
- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment perioddate_rangeTime Frame:Baseline and week 12 to 16enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in local laboratory hemoglobin level from baselinedate_rangeTime Frame:Baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Speed of change in hemoglobin level per unit timedate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Duration of treatment exposuredate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 16 weeksenhanced_encryptionYesSafety Issue:
- Pharmacodynamics characterized by erythropoietin concentrationdate_rangeTime Frame:Several time points up to 16 weeksenhanced_encryptionNoSafety Issue:
- Pharmacodynamics characterized by reticulocyte countdate_rangeTime Frame:Several time points up to 16 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6